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CompletedNCT01037855Updated Mar 14, 2017

Observational Study of Safety of Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine

An observational study in Novel Influenza A (H1N1) and A New Flu Virus of Swine Origin, sponsored by Novartis Vaccines. Completed at 10 sites in 4 countries. Open to participants aged 6 Months and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-14.

Sponsored by Novartis Vaccines · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
4,028
Ages
6 Months and older
Sex
All
01

Study summary

This is an observational study of safety and occurrence of influenza-like illness following administration of flu cell culture derived adjuvanted swine origin A (H1N1) pandemic subunit vaccine in subjects 6 months of age and older.

02

Conditions studied

  • Novel Influenza A (H1N1)
  • A New Flu Virus of Swine Origin

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Keywords

  • Swine Flu H1N1 vaccine
  • Adjuvanted flu cell culture derived
03

In context

Influenza, Human

2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.

This study's enrollment of 4,028 is above the median of 300 across 305 observational studies indexed under Influenza, Human.

Browse Influenza, Human studies →

Lead sponsor

Novartis Vaccines is the lead sponsor of 161 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Months and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

population of children, adolescents, adults and elderly

Inclusion criteria

  • Age ≥ 6 months
  • Subjects will be vaccinated with Flu Cell Culture Derived Adjuvanted Swine Origin A (H1N1) Pandemic Subunit Vaccine, independently of this study.
  • Subjects or parent/guardian willing to provide informed consent prior to vaccination administration and complete all of the study, including follow-up contact

Exclusion criteria

Exclusion Criteria:

  • Received any prior H1N1 vaccination
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
4,028 participants (actual)

Groups and cohorts

  • Group 1: 6-23 months

    Other: Non-intervention observational study

  • Group 2: 2-8 years

    Other: Non-intervention observational study

  • Group 3: 9-17 years

    Other: Non-intervention observational study

  • Group 4: 18-44 years

    Other: Non-intervention observational study

  • Group 5: 45-60 years

    Other: Non-intervention observational study

  • Group: >60 years

    Other: Non-intervention observational study

Interventions

  • OtherNon-intervention observational study

    Non-intervention observational study

06

What researchers measure

Primary outcomes

  1. To quantify the safety of Flu Cell Culture Derived Adjuvanted Swine Origin A(H1N1) Pandemic Subunit Vaccine in actively monitored subjects

    Time frame: 6 months

  2. To characterize the incidence of AEs in specific age groups following an active surveillance of vaccinated subjects

    Time frame: 6 months

Secondary outcomes

  1. To assess the occurrence of laboratory confirmed H1N1sw and influenza-like illness following vaccination

    Time frame: 6 Months

07

Study locations

10 sites
  • Clinica Indisa
    Av. Santa Maria, Santiago 1810, Chile
  • Fundación Universitaria de Ciencias de Salud- Hospital San José Calle
    Bogota, Colombia
  • Nueva EPS: Centro de Especialistas Barrios Unidos - MEDERI
    Calle 66 # 40-07 - Bogotá, Colombia
  • Hospital local de Yopal E.S.E
    Calle 9 No. 24-37 - Yopal, Casanare, Colombia
  • Clinica del Country
    Carrera 16 No. 82-57 Bogotá, Colombia
  • Hospital Universitario Infantil San José
    Carrera 52 No. 67A-71 - Barrios Unidos - Bogotá, Colombia
  • CAIMED - Centro de Atencion e Investigación Medica
    Cra. 42 A No. 17-50, Colombia
  • Augustenburger Platz 1, Berlin, Germany
  • Policlinique Médicale Universitaire
    Rue du Bugnon 44, CH-1011 Lausanne, Switzerland
  • Institute of Social and Preventive Medicine, Division of Communicable Diseases
    Hirschengraben 84, CH-8001 Zürich, Switzerland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01037855
Lead sponsor
Novartis Vaccines
Responsible party
Sponsor
First posted
Dec 23, 2009
Start date
Dec 2009
Primary completion
Jun 2010
Completion
Jan 2011
Last update
Mar 14, 2017
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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